medical devices

The U.S. Food and Drug Administration (FDA) has extended the deadline for certain low-risk...

This article focuses on global wireless compliance. More specifically, it explains what to consider if you intend to certify your device with an integrated third-party module internationally.

A new type of pacemaker runs without wires or a battery, and is completely changing medical technology.

This article will focus on the U.S. Food and Drug Administration’s guidance documents and the standards applicable to wearable medical and wellness devices.

Clients who engage us for FDA 510(k) submission consulting often ask what testing is required by the FDA to clear their device. While testing requirements are easy to determine for some devices, other devices require intensive research.

A new lightweight, flexible sensor can target and detect the levels of hydration on a person's skin.

The U.S. Food and Drug Administration (FDA) has identified an extensive list of Class...

The U.S. Food and Drug Administration (FDA) has proposed exempting several hundred medical devices...

As part of its effort to create a more formalized system of registration requirements,...

A recent survey conducted by the Emergo Group indicates that 2017 is expected to...